This is a first in human study to identify whether FP-1305 is suitable to use in humans. The previous pre-clinical studies have demonstrated that FP-1305 binds to a receptor known as CLEVER-1. CLEVER-1 has been shown to support tumour growth. No significant adverse events were witnessed in primates and the dose used will be 300 fold lower than the dose provided to primates which showed no toxicity. The patients with advanced melanoma, uveal melanoma, cholangiocarcinoma, gallbladder cancer, ER+ breast, gastric, ovarian, pancreatic, colorectal, liver or anaplastic thyroid cancer who have exhausted all licenced therapeutic options will die due to their disease. Based on the investigator's existing data CLEVER-1 is expressed in these tumour types. Inhibition of CLEVER-1 with FP-1305 may have an anti-tumour effect in these patients.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
216
The study will test for the first time in patients with cancer, an experimental medicine, called FP-1305. The study goal is to find the dose of FP-1305 that works best against cancer while it remains safe for use, tolerable and effective in patients with cancer.
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Clinical Research Institute HUCH Ltd
Helsinki, Finland
Oulu University Hospital
Oulu, Finland
Tampere University Hospital
Tampere, Finland
Turku University Hospital
Turku, Finland
The Institut Gustave Roussy
Villejuif, France
Erasmus University Medical Center Rotterdam
Rotterdam, Netherlands
START Madrid - CIOCC Hospital HM Sanchinarro
Madrid, Spain
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, United Kingdom
Queen Elizabeth Hospital Birmingham
Birmingham, United Kingdom
...and 1 more locations
Dose Limiting Toxicities (DLT) in the Trial Subjects.
Tolerable dose(s) will be determined by the TITE-CRM based on the occurrence/non-occurrence of dose limiting toxicities in the trial subjects.
Time frame: Up to one year
Number of Participants With Treatment Emergent Adverse Events (Safety and Tolerability)
Number of adverse events and serious adverse events. Adverse events are collected, graded and reported according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
Time frame: approximately 4 years and 9 months
The Response Objective Response Rate (ORR) to the Treatment Was Planned to be Determined by Tumor Imaging According to RECIST 1.1.
The objective response rate (ORR) to the treatment will be determined by tumour imaging (tumor size) according to RECIST v.1.1. Results from each tumour type, dose level and dosing frequency are reported separately.
Time frame: approximately 4 years and 9 months
The Disease Control Rate (DCR) Response to the Treatment Was Planned to be Determined by Tumor Imaging According to RECIST 1.1.
The disease control rate (DCR) response to the treatment will be determined by tumour imaging (tumor size) according to RECIST v.1.1 are presented by cycles and by doing so there is no difference in the definition of DCR and Clinical Benefit Rate (CBR)
Time frame: approximately 4 years and 9 months
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